Quality Systems Engineering Manager
Rakuten Medical
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $140,000 - $160,000 per year
About the role
- Oversee the implementation, maintenance, and improvement of the QMS
- Lead Management Reviews and ensure top-level quality engagement
- Conduct internal audits and prepare for external inspections
- Manage document control processes utilizing Arena for product lifecycle management
- Oversee supplier qualification and auditing processes
- Own and manage the CAPA and non-conformance systems
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related field
- ISO 13485:2016 Lead Auditor Certification (required)
- Minimum 8-10 years of experience managing quality systems in regulated industries
- Strong working knowledge of ISO standards and FDA regulations
- Proficiency in QMS software (e.g., Arena, MasterControl)
Benefits
- Flexible time off
- Stock options
- 401k
- Medical plans
- Dental plans
- Vision plans
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
QMS managementinternal auditsdocument controlCAPA managementnon-conformance managementsupplier qualificationregulatory compliance
Soft Skills
leadershipcommunicationorganizational skills
Certifications
ISO 13485:2016 Lead Auditor Certification